Agenda/Scientific Program
The Forum will bring together industry, regulatory, and academic professionals to explore a number of critical topics focused on improving the quality in development and manufacturing of biopharmaceutical products. Speaker presentations will be followed by an in-depth panel discussion. We look forward to an informative Forum and hope to see you there. Be ready to collaborate and expand your knowledge.
Session I - Convergence of Regulatory Variation Category Assignment and Defined HA Review Timelines Through Risk-Based Assessment of PACs | Tuesday, 6 August 2024 | 13:00 BRT
This Session
will continue conversations for understanding barriers enabling risk-based classification of PACs, promoting convergence of regulatory variation reporting category assignment and defined HA review timelines and partner with HAs in the regions to identify
pragmatic solutions like Reliance enabling regulatory efficiencies.
Session II - Streamline Management of Product Life Cycle Changes and Build Regulatory Efficiencies Leveraging Reliance | Tuesday, 13 August 2024 | 13:00 BRT
This Session aims to understand opportunities
and challenges of implementing reliance in the region, how can industry partner with the HAs to move this along, are there other regulatory mechanisms that might be beneficial to consider?
Click on the sections below for detailed information:
Session I - Convergence of Regulatory Variation Category Assignment and Defined HA Review Timelines Through Risk-Based Assessment of PACs | Tuesday, 6 August 2024 | 13:00 BRT
Simplification of the regulatory processes and adhering to common fundamentals for managing post-approval changes would enable international collaboration and cooperation towards regulatory convergence and consequentially speed to market of quality medicines. This can be achieved by harmonized change classifications, leveraging scientific risk-based principles for regulatory evaluations and decision making, adherence to defined and predictable review timelines, collaboration and open dialogues between industry and regulators as well as the use of novel regulatory, and scientific tools and practices.
This Session will continue conversations for understanding barriers enabling risk-based classification of PACs, promoting convergence of regulatory variation reporting category assignment and defined HA review timelines and partner with HAs in the regions to identify pragmatic solutions like Reliance enabling regulatory efficiencies.
Session II - Streamline Management of Product Life Cycle Changes and Build Regulatory Efficiencies Leveraging Reliance | Tuesday, 13 August 2024 | 13:00 BRT
Post-approval changes (PACs) are an essential part of product lifecycle management. Bringing CMC changes through global health authority (regulatory) systems can be a complex, lengthy process taking several years and their timely approval is critical to maintaining and ensuring continuous supply of quality medicinal products. On the face of regulatory diversity amongst National Regulatory Authorities (NRAs), WHO strongly encourages abridged regulatory pathway like “Reliance” as an effective solution fostering more equitable and timely access to quality-assured medical products. Relying on the assessment performed by a reference regulatory authority will build regulatory efficiencies for both health agencies and industry by optimizing use of effort and resources and eliminating redundancies.
This Session aims to understand opportunities and challenges of implementing reliance in the region, how can industry partner with the HAs to move this along, are there other regulatory mechanisms that might be beneficial to consider?
Thank You for Joining Us
We appreciate your participation in Session I on 6 August 2024 and Session II on 13 August 2024 and hope you consider joining us next time. More information coming soon.
